Integrating QbD and Biopharmaceutics: The Nine Synergistic Areas for Optimizing Product Quality for Patient Benefit
*Arzu Selen, FDA 


The principles of this presentation originated in a conference held in June 2009 in Rockville, MD for integration of biopharmaceutics and Quality by Design (QbD) for dissolution specification setting and enhancing product quality for patient benefit. The 2009 meeting concluded with identification of nine priority/synergistic areas that enable integration of biopharmaceutics with QbD starting with patient benefit at the core, as reflected in the Quality Target Product Profile (QTPP). The biopharmaceutics risk assessment road map/plan serves as a bridge and facilitates identification and integration of critical in vitro and in vivo factors derived from mechanistic predictive studies and use of statistical and computational methods. This integrated and multidimensional approach will be presented as a means for optimizing product quality by linking process, product and patient benefit.